Efficacy of ziprasidone monotherapy in patients with anxious depression: A 12-week, randomized, double-blind, placebo-controlled, sequential-parallel comparison trial

Journal of Psychiatric Research

Volumn 62, Issue , 2015, Pages 56-61

  Heo, Jung Yoon ^a   Jeon, Hong Jin ^a,b,c   Fava, Maurizio ^b   Mischoulon, David ^b   Baer, Lee ^b   Clain, Alisabet ^b   Doorley, James ^b   Pisoni, Angela ^b   Papakostas, George I ^b  

^a Sungkyunkwan University School of Medicine   (South Korea)

^b HARVARD MEDICAL SCHOOL   (United States)

^c Sungkyunkwan University   (South Korea)

Author keywords

Anxious depression; Efficacy; Major depressive disorder; Monotherapy; Ziprasidone

Indexed keywords

PLACEBO; ZIPRASIDONE; ANTIDEPRESSANT AGENT; PIPERAZINE DERIVATIVE; THIAZOLE DERIVATIVE;

ADULT; ANXIETY ASSESSMENT; ANXIETY DISORDER; ANXIOUS DEPRESSION; ARTICLE; CHRONOTHERAPY; CONTROLLED STUDY; DEPRESSION ASSESSMENT; DOSE RESPONSE; DOUBLE BLIND PROCEDURE; DRUG DOSE INCREASE; DRUG EFFICACY; FEMALE; HAMILTON DEPRESSION RATING SCALE; HUMAN; MAJOR CLINICAL STUDY; MAJOR DEPRESSION; MALE; MENTAL PATIENT; MONOTHERAPY; MULTICENTER STUDY (TOPIC); MULTIPLE CYCLE TREATMENT; OUTPATIENT; PARALLEL DESIGN; PHASE 1 CLINICAL TRIAL; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PSYCHOPHARMACOTHERAPY; QUICK INVENTORY OF DEPRESSIVE SYMPTOMATOLOGY SCALE SELF RATED; RANDOMIZED CONTROLLED TRIAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); TREATMENT DURATION; TREATMENT OUTCOME; TREATMENT RESPONSE; CLINICAL TRIAL; COMPLICATION; DEPRESSION; MIDDLE AGED; MULTICENTER STUDY; PSYCHOLOGICAL RATING SCALE;

ADULT; ANTIDEPRESSIVE AGENTS; ANXIETY DISORDERS; DEPRESSION; DOUBLE-BLIND METHOD; FEMALE; HUMANS; MALE; MIDDLE AGED; PIPERAZINES; PSYCHIATRIC STATUS RATING SCALES; THIAZOLES; TREATMENT OUTCOME;

EID: 84924340333     PISSN: 00223956     EISSN: 18791379     Source Type: Journal    
DOI: 10.1016/j.jpsychires.2015.01.007     Document Type: Article

References (35)

1. American Psychiatric Association Diagnostic and statistical manual of mental disorders (DSM-V) 2013, American Psychiatric Press, Washington (DC). 5th ed.
2. Bandelow B., Bauer M., Vieta E., El-Khalili N., Gustafsson U., Earley W.R., et al. Extended release quetiapine fumarate as adjunct to antidepressant therapy in patients with major depressive disorder: pooled analyses of data in patients with anxious depression versus low levels of anxiety at baseline. World J Biol Psychiatry 2014, 15:155-166.
3. Cleary P., Guy W. Factor analysis of the Hamilton depression scale. Drugs Exp Clin Res 1977, 1:115-120.
4. Daniel D.G., Zimbroff D.L., Potkin S.G., Reeves K.R., Harrigan E.P., Lakshminarayanan M. Ziprasidone 80 mg/day and 160 mg/day in the acute exacerbation of schizophrenia and schizoaffective disorder: a 6-week placebo-controlled trial. Ziprasidone study group. Neuropsychopharmacology 1999, 20:491-505.
5. Dunner D.L., Amsterdam J.D., Shelton R.C., Loebel A., Romano S.J. Efficacy and tolerability of adjunctive ziprasidone in treatment-resistant depression: a randomized, open-label, pilot study. JClin Psychiatry 2007, 68:1071-1077.
6. Fava M., Alpert J.E., Carmin C.N., Wisniewski S.R., Trivedi M.H., Biggs M.M., et al. Clinical correlates and symptom patterns of anxious depression among patients with major depressive disorder in STAR*D. Psychol Med 2004, 34:1299-1308.
7. Fava M., Evins A.E., Dorer D.J., Schoenfeld D.A. The problem of the placebo response in clinical trials for psychiatric disorders: culprits, possible remedies, and a novel study design approach. Psychother Psychosom 2003, 72:115-127.
8. Fava M., Martinez J.M., Greist J., Marangell L.B., Brown E., Chen L., et al. The efficacy and tolerability of duloxetine in the treatment of anxious versus non-anxious depression: a post-hoc analysis of an open-label outpatient study. Ann Clin Psychiatry 2007, 19:187-195.
9. Fava M., Rush A.J., Alpert J.E., Balasubramani G.K., Wisniewski S.R., Carmin C.N., et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. Am J Psychiatry 2008, 165:342-351.
10. Fava M., Schaefer K., Huang H., Wilson A., Iosifescu D.V., Mischoulon D., et al. Apost hoc analysis of the effect of nightly administration of eszopiclone and a selective serotonin reuptake inhibitor in patients with insomnia and anxious depression. JClin Psychiatry 2011, 72:473-479.
11. Fawcett J., Kravitz H.M. Anxiety syndromes and their relationship to depressive illness. JClin Psychiatry 1983, 44:8-11.
12. Hamilton M. Arating scale for depression. JNeurol Neurosurg Psychiatry 1960, 23:56-62.
13. Il'ina N.A. Experience of the use of velaxin (venlafaxine) in anxious depression. Neurosci Behav Physiol 2009, 39:305-309.
14. Ionescu D.F., Niciu M.J., Mathews D.C., Richards E.M., Zarate C.A. Neurobiology of anxious depression: a review. Depress Anxiety 2013, 30:374-385.
15. Jeon H.J., Fava M., Mischoulon D., Baer L., Clain A., Doorley J., et al. Psychomotor symptoms and treatment outcomes of ziprasidone monotherapy in patients with major depressive disorder: a 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial. Int Clin Psychopharmacol 2014, 29:332-338.
16. Joffe R.T., Bagby R.M., Levitt A. Anxious and nonanxious depression. Am J Psychiatry 1993, 150:1257-1258.
17. Nemeroff C.B., Lieberman J.A., Weiden P.J., Harvey P.D., Newcomer J.W., Schatzberg A.F., et al. From clinical research to clinical practice: a 4-year review of ziprasidone. CNS Spectr 2005, 10:1-20.
18. Newman-Tancredi A., Gavaudan S., Conte C., Chaput C., Touzard M., Verriele L., et al. Agonist and antagonist actions of antipsychotic agents at 5-HT1A receptors: a [35S]GTPgammaS binding study. Eur J Pharmacol 1998, 355:245-256.
19. Nyberg S., Jucaite A., Takano A., Kagedal M., Cselenyi Z., Halldin C., et al. Norepinephrine transporter occupancy in the human brain after oral administration of quetiapine XR. Int J Neuropsychopharmacol 2013, 16:2235-2244.
20. Papakostas G.I., Fan H., Tedeschini E. Severe and anxious depression: combining definitions of clinical sub-types to identify patients differentially responsive to selective serotonin reuptake inhibitors. Eur Neuropsychopharmacol 2012, 22:347-355.
21. Papakostas G.I., Larsen K. Testing anxious depression as a predictor and moderator of symptom improvement in major depressive disorder during treatment with escitalopram. Eur Arch Psychiatry Clin Neurosci 2011, 261:147-156.
22. Papakostas G.I., Vitolo O.V., Ishak W.W., Rapaport M.H., Zajecka J.M., Kinrys G., et al. 12-week, randomized, double-blind, placebo-controlled, sequential parallel comparison trial of ziprasidone as monotherapy for major depressive disorder. JClin Psychiatry 2012, 73:1541-1547.
23. Prieto E., Mico J.A., Meana J.J., Majadas S. Neurobiological bases of quetiapine antidepresant effect in the bipolar disorder. Actas Esp Psiquiatr 2010, 38:22-32.
24. Richelson E., Souder T. Binding of antipsychotic drugs to human brain receptors focus on newer generation compounds. Life Sci 2000, 68:29-39.
25. Robinson D.S., Rickels K., Feighner J., Fabre L.F., Gammans R.E., Shrotriya R.C., et al. Clinical effects of the 5-HT1A partial agonists in depression: a composite analysis of buspirone in the treatment of depression. JClin Psychopharmacol 1990, 10:67S-76S.
26. Rollema H., Lu Y., Schmidt A.W., Sprouse J.S., Zorn S.H. 5-HT(1A) receptor activation contributes to ziprasidone-induced dopamine release in the rat prefrontal cortex. Biol Psychiatry 2000, 48:229-237.
27. Seo H.J., Jung Y.E., Kim T.S., Kim J.B., Lee M.S., Kim J.M., et al. Distinctive clinical characteristics and suicidal tendencies of patients with anxious depression. JNerv Ment Dis 2011, 199:42-48.
28. Sheehan D.V., Lecrubier Y., Sheehan K.H., Amorim P., Janavs J., Weiller E., et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. JClin Psychiatry 1998, 59(Suppl.20):34-57. 22-33;quiz.
29. Stahl S.M., Shayegan D.K. The psychopharmacology of ziprasidone: receptor-binding properties and real-world psychiatric practice. JClin Psychiatry 2003, 64(Suppl.19):6-12.
30. Tamura R.N., Huang X. An examination of the efficiency of the sequential parallel design in psychiatric clinical trials. Clin Trials 2007, 4:309-317.
31. Tatsumi M., Jansen K., Blakely R.D., Richelson E. Pharmacological profile of neuroleptics at human monoamine transporters. Eur J Pharmacol 1999, 368:277-283.
32. Thase M.E., Demyttenaere K., Earley W.R., Gustafsson U., Udd M., Eriksson H. Extended release quetiapine fumarate in major depressive disorder: analysis in patients with anxious depression. Depress Anxiety 2012, 29:574-586.
33. Tollefson G.D., Holman S.L., Sayler M.E., Potvin J.H. Fluoxetine, placebo, and tricyclic antidepressants in major depression with and without anxious features. JClin Psychiatry 1994, 55:50-59.
34. Trivedi M.H., Rush A.J., Ibrahim H.M., Carmody T.J., Biggs M.M., Suppes T., et al. The Inventory of Depressive Symptomatology, Clinician Rating (IDS-C) and Self-Report (IDS-SR), and the Quick Inventory of Depressive Symptomatology, Clinician Rating (QIDS-C) and Self-Report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med 2004, 34:73-82.
35. Vrieze E., Demyttenaere K., Bruffaerts R., Hermans D., Pizzagalli D.A., Sienaert P., et al. Dimensions in major depressive disorder and their relevance for treatment outcome. JAffect Disord 2014, 155:35-41.